PharmaSUG 2017 - Paper DS25
A Critique of Implementing the Submission Data Tabulation Model (SDTM) for Drugs and Medical Devices Carey G. Smoak, DataCeutics, Inc.
The Clinical Data Interchange Standards Consortium (CDISC) encompasses a variety of standards for medical research. Amongst the several standards developed by the CDISC organization are standards for data collection (Clinical Data Acquisition Standard Harmonization - CDASH), data submission (Study Data Tabulation Model - SDTM) and data analysis (Analysis Data Model - ADaM). Drug development was the original impetus for developing these standards. Therapeutic Area User Guides (TAUGs) have been a recent focus to provide advice, examples and explanations for collecting and submitting data for a specific disease. Non-subjects even have a way to collect data using the Associated Persons Implementation Guide (SDTMIG-AP). SDTM domains for medical device were published 2012. Interestingly, the use of Device domains in the TAUGs occurs in seventeen out of twenty-four of TAUGs providing examples of the use of the various Device domains. Drug-device studies also provide a contrast on adoption of CDISC standard for drug submissions versus device submissions. Adoption of SDTM (in general and the seven Device domains) by the medical device industry has been slow. Reasons for this slow adoption and suggestions for solutions adoption will be discussed. Click here for the full article.